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Drug Regulatory Affairs in Drug Development

Course content

All aspects within the pharmaceutical development process of
medicinal products are subject to various degree of regulation. The
pharmaceutical law frame, guidelines covering Quality, Safety and
Efficacy as well as Health Authorities' attitudes and
requirements etc. have a great influence on the drug development
process and the success of it. Regulatory affairs professionals
deal with these aspects. Knowing this discipline and how to focus
the development process and co-operate with the regulatory affairs
professionals can be vital for the success of a medicinal product
development and so the survival of a pharmaceutical company.

The contents will cover the role and responsibility for the drug
regulatory affairs professionals – how they are involved in the
development process, how to co-operate with this function, the
pharmaceutical law frame in EU, US and outside EU/US, the
application and approval procedures, regulatory strategic issue,
how to build up an application for a marketing authorization,
variations, incentives, pharmacovigilance, and how to approach the
issues of Quality, Safety and Efficacy from a regulatory point of
view.

This course is a compulsory course at the Master's Programme
in Industrial Drug Development.

The course serves as continuing professional development (CPD) for
drug development professionals interested in or working under drug
regulation, e.g. employees in QA/QC, CMC, analytical development
and pharmaceutical development.

Master’s level (second cycle higher education). Open for freelance
students who meet the admission criteria. Compulsory for MIND
students, elective for other part-time master's students.
(subject to study board approval).

The course will consist of 15-20 lectures over a 5-day period.
Each lecture will leave time for extensive discussions facilitating
active participation by the participant. Group discussions and case
stories will be an important part of the course.

The test is composed of essay questions. The purpose of the
examination is to test that the examinee has achieved the expected
learning outcomes. The percentage of items on the test devoted to a
particular topic will roughly correspond to the emphasis given the
topic in teaching of the course, and as implied in the general
course objectives and content.

Aid

Written aids allowed

Calculators are not allowed.
Apart from the standard programs and IT tools listed under The
Faculty of Health and Medical Sciences at
http://pc-eksamen.ku.dk/pc_exam
students will at this exam also have access to use a USB stick (for
notes etc.)

Marking scale

7-point grading scale

Censorship form

External censorship

Criteria for exam assessment

Knowledge:

Give an overview of how, when and with whom regulatory affairs
interact with the drug development process, particularly with
quality, safety and efficacy

Recognize the different types of applications and application
procedures available in the EU, US and outside EU/US